POS1524 DURABLE CLINICALLY-MEANINGFUL IMPROVEMENTS IN HEALTH-RELATED QUALITY OF LIFE, FATIGUE, PAIN, AND WORK PRODUCTIVITY AMONG PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS TREATED WITH RISANKIZUMAB AT WEEK 100
Authors: L. E. Kristensen, A. M. Soliman, B. Padilla, K. Papp, A. Ostor
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Risankizumab (RZB) demonstrated efficacy and safety in the treatment of psoriatic arthritis (PsA) in phase 3 trials KEEPsAKE-1 (NCT03675308), patients with an inadequate response to disease-modifying antirheumatic drugs (DMARD-IR), and KEEPsAKE-2 (NCT03671148), DMARD-IR and inadequate responders to biologics. <h3>Objectives</h3> This analysis aims to assess the durability of the RZB treatment response on health-related quality of life (HRQoL) and patient-reported outcomes (PROs) in patients with PsA at Week 100. <h3>Methods</h3> In the KEEPsAKE 1 and 2 trials, patients were randomised 1:1 to receive RZB 150 mg or PBO in the 24-week double-blind period. During the open-label maintenance period, all patients received RZB 150 mg. This analysis evaluated observed cases of RZB-treated patients who achieved minimal clinically important differences (MCIDs) in PROs at Week 24. Results are presented as the percentage of patients, of those who achieved MCIDs at Week 24, who maintained MCIDs in PROs from Week 52 to Week 100. MCIDs included a ≥10-point decrease in Patient's Global Assessment (PtGA), ≥10-point decrease in Pain, ≥0.35-point decrease in Health Assessment Questionnaire – Disability Index (HAQ-DI), ≥4-point decrease in Functional Assessment of Chronic Illness Therapy (FACIT) – Fatigue, ≥2.5-point increase in 36-Item Short Form Survey (SF-36) physical component summary (PCS), ≥1.1-point decrease in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), ≥1-point decrease in morning stiffness, and ≥20% reduction in Work Productivity and Activity Impairment Questionnaire (WPAI) Presenteeism, ≥15% in Work Productivity Loss, and ≥20% in Activity Impairment. <h3>Results</h3> In KEEPsAKE 1, 54–68% and 31–52% of RZB-treated patients and PBO to RZB patients achieved MCIDs across PROs at Week 24, respectively. In KEEPsAKE 2, 44–67% and 33–47% of RZB-treated patients and PBO to RZB patients achieved MCIDs across PROs at Week 24, respectively. Among the patients who achieved MCIDs at Week 24 in KEEPsAKE 1, a high percentage of RZB and PBO to RZB-treated patients maintained MCIDs from Week 52 to 100 in PtGA (RZB: 85.3–88.9%; PBO to RZB: 87.2–91.4%), Pain (RZB: 84.7–88.4%; PBO to RZB: 87.0–90.9%), and HAQ-DI (RZB: 87.0–90.8%; PBO to RZB: 82.6–84.3%) (<b>Figure 1</b>). In KEEPsAKE 2, similarly high percentages of RZB and PBO to RZB-treated patients maintained MCIDs in PtGA (RZB: 77.0–80.5%; PBO to RZB: 78.4–84.0%), Pain (RZB: 77.2–85.6%; PBO to RZB: 84.3–94.2%), and HAQ-DI (RZB: 74.0–83.8%; PBO to RZB: 89.6–95.8%). At Week 100, 77.6–88.9% and 73.5–95.5% of RZB and PBO to RZB-treated patients, respectively, in KEEPsAKE 1 maintained MCIDs in FACIT-Fatigue, SF-36 PCS, BASDAI, morning stiffness, and WPAI; similar results were demonstrated in KEEPsAKE 2 (RZB: 73.1–96.4%; PBO to RZB: 76.2–100.0%) (<b>Table 1</b>). <h3>Conclusion</h3> In KEEPsAKE 1 and 2 trials, the majority of RZB-treated patients with PsA who achieved MCID in PROs at Week 24 maintained responses through Week 100. Achieving MCIDs at Week 24 is associated with sustained and clinically meaningful changes in HRQoL. <h3>Acknowledgements</h3> AbbVie funded the study and participated in interpretation of data, review, and approval of the abstract. All authors contributed to development of the abstract and maintained control over final content. No honoraria or payments were made for authorship. Medical writing services provided by Natalie Mitchell (Fishawack Facilitate Ltd) and funded by AbbVie. <h3>Disclosure of Interests</h3> Lars Erik Kristensen Speakers bureau: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, and UCB, Ahmed M. Soliman Shareholder of: full-time employee of AbbVie and may hold AbbVie stock and/or stock options and patents, Employee of: full-time employee of AbbVie and may hold AbbVie stock and/or stock options and patents, Byron Padilla Shareholder of: full-time employee of AbbVie and may hold AbbVie stock and/or stock options and patents, Employee of: full-time employee of AbbVie and may hold AbbVie stock and/or stock options and patents, Kim Papp Speakers bureau: AbbVie, Amgen, Astellas, Bausch Health (Valeant), Baxalta, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, Dermira, EMD Serono, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Kirin, Lilly, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Stiefel, Sun Pharma, Takeda and UCB, Consultant of: AbbVie, Amgen, Astellas, Bausch Health (Valeant), Baxalta, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, Dermira, EMD Serono, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Kirin, Lilly, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Stiefel, Sun Pharma, Takeda and UCB, Grant/research support from: AbbVie, Amgen, Astellas, Bausch Health (Valeant), Baxalta, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, Dermira, EMD Serono, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Kirin, Lilly, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Stiefel, Sun Pharma, Takeda and UCB, Andrew Ostor Speakers bureau: AbbVie, Bristol Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and UCB, Consultant of: AbbVie, Bristol Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and UCB, Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and UCB.